Regulatory Affairs Specialist
17211 Red Hill Avenue Irvine, CA 92614 US
Job Description
*Depending on experience
Purpose: Completes and maintains regulatory approvals and clearances of medical device products.
Key Responsibilities:
1. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements. Present alternatives for meeting regulatory requirements and resolve conflicts between those requirements and development issues, and/or reporting to management.
2. Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions.
3. May interact with regulatory agencies as part of submission review and on-site audit support (e.g., US FDA, EU notified bodies, Japan PMDA, Australia TGA, Japan PMDA, other global regulatory agencies, submissions, dossiers and technical files)
4. Provide guidance on regulatory requirements necessary for contingency planning
5. Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes suggestions on utilizing regulatory updates to expedite approval process
6. Review labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
7. Prepare documents for submissions to global regulatory bodies.
Experience:
-Experience with EU MDR preferred
-Coursework, seminars, and/or other formal government and/or trade association training required
-Proven expertise in Microsoft Office, Adobe.
-Experience in product lifecycle management systems (Agile, Teamcenter etc.) preferred
-Good written and verbal communication skills and interpersonal relationship skills
-Good problem-solving, organizational, analytical and critical thinking skills
Additional Skills:
-Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
-Ability to build productive internal/external working relationships
-Develops solutions to a variety of problems of moderate scope and complexity
-Contributes to process improvements
-Exercise judgment within defined procedures and practices to determine appropriate regulatory action/requirements for new products or product changes and preparation of regulatory documents.
Education and Experience:
-Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
-2-4 years of experience required
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